Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-10-15

Brief Summary

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This study aims to investigate the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer.

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Detailed Description

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This is a randomized, double-blind,controlled, parallel study that will be conducted on patients with oxaliplatin induced peripheral neuropathy with gastrointestinal cancer.

This study will be done on 93 patients with gastrointestinal cancer (colon or gastric or pancreatic) cancer on standard FOLFOX-4 regimen who will divided into 3 groups:

Group 1: 31 Patients who will receive standard chemotherapy plus duloxetine 30 mg/day for 12 cycles (up to 6 months).

Group 2: 31 Patients who will receive standard chemotherapy plus gabapentin 300 mg/day for 12 cycles (up to 6 months).

Group 3: 31 Patients who will receive standard chemotherapy plus lacosamide 50 mg/day for 12 cycles (up to 6 months).

Conditions

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Oncology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

double blind

Study Groups

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Duloxetine

group 1

Group Type EXPERIMENTAL

Duloxetine

Intervention Type OTHER

Duloxetine 30mg / day for 12 cycles (up to 6 months)

Gabapentin

group 2

Group Type EXPERIMENTAL

Gabapentin

Intervention Type OTHER

Gabapentin 300 mg / day for 12 cycles (up to 6 months)

Lacosamide

group 3

Group Type EXPERIMENTAL

Lacosamide

Intervention Type OTHER

Lacosamide 50 mg / day for 12 cycles (up to 6 months)

Interventions

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Duloxetine

Duloxetine 30mg / day for 12 cycles (up to 6 months)

Intervention Type OTHER

Gabapentin

Gabapentin 300 mg / day for 12 cycles (up to 6 months)

Intervention Type OTHER

Lacosamide

Lacosamide 50 mg / day for 12 cycles (up to 6 months)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A) Adults ≥ 18 years old male and female patients. B) Patients with gastrointestinal cancer receiving oxaliplatin chemotherapy

Exclusion Criteria

* A) Preexisting neuropathic or brain disorders. B) Previous use of chemotherapeutic agents including taxanes, platinum, vinca alkaloids, and bortezomib.

C) Concomitant use of drugs reported to have neuroprotective role and analgesics.

D) Patients with diabetes, uncontrolled hypertension, congestive heart failure, drug addiction and patients who were receiving tamoxifen.

E) Patients with abnormal renal function tests (serum creatinine ≤ 30 ml/min) or liver function tests (≥ 3 times the upper normal range).

F) Participants with a documented medical history of neuropathy. G) Concomitant use of other antidepressants, anticonvulsants, high-dose vitamin supplements or drugs known to influence serotonin levels.

H) Pregnancy and lactating women. I) Uncooperative patients and patients who have psychological problems or on antipsychotic medications.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No